Annual Product Quality Reviews; Understanding the Evolution of Regulatory Requirements for the Product Review

Live, Interactive Training Webinar

Date: Wednesday April 17, 2019
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Jerry Lanese Ph.D. Biography>>>

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There have been many changes in the pharmaceutical industry since the release of 21CFR211, the Drug GMPs, in 1978. At that time, the products were mainly small molecule with a few antibiotics. There were no or few generic products. The industry was dominated by a relatively small number of ‘Big pharma” organizations that marketed domestically. We now have sophisticated parenteral, biological and combination products and new processing techniques. The industry includes many virtual organizations. There are products, businesses and processes not imagined in 1978. Through this time countries have issued or revised regulations to reflect current practices and the FDA and other organizations have introduced the concept of the quality system and issued guidance documents such as ICH Q10, the Pharmaceutical Quality System and Process Validation. Regulatory agencies throughout the world have issued new or revised regulations that reflect the contemporary industry. The impact of all of these industry changes on compliance and the preparation of the product review will be discussed.

The discussion will begin with the impact of the introduction of generic products in the 1980s and work through the globalization of the industry, introduction new technology and new business practices. The regulatory agencies throughout the world have responded with a wide range of regulations and guidances. The impact of the following guidances such as the following (and more) on compliance and product review preparation and content will be discussed:

- Investigation of OOS Results in the Laboratory
- FDA Process Validation Guidance
- ICH Q8: Pharmaceutical Development
- ICH Q9: Quality Risk Management
- ICH Q10: The Pharmaceutical Quality system
- Quality Metrics

Although the 1978 GMPs have not changed, the product mix, technology, industry business practices and move to globalization have driven an evolution in the interpretation and enforcement of the regulations.

Learning Benefits:
The evolution of drug products
The evolution of the pharmaceutical industry
The evolution of requirements for the Product Review
The impact of the Quality System concept

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Presentation Part 1,
11:30 AM Break
11:40 AM Presentation Part 2,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

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Instructor: John G. (Jerry) Lanese Ph.D.

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry… Full Bio>>>


Course Number: 274

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